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CompletedPhase 4

Escitalopram Treatment of Patients With Agitated Dementia

Escitalopram in the Treatment of Patients With Agitated Dementia

Asset

Escitalopram

Listed sites

3

Recruiting sites

-

Enrollment

20

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Agitation factor on the Neurobehavioral Rating Scale (NBRS)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDLXP MD 43
NCT IDNCT00260624

Timeline

Milestones

Study start2003-02 (month precision)
Study first posted2005-12-01estimated
Primary completion2006-12actual (month precision)
Study completion2006-12actual (month precision)
Last update posted2012-02-24estimated

Assets

Drug assets

Escitalopram

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age61 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Dementia of Alzheimer's type with behavioral disturbance
•Mild to severe cognitive impairment
•Age over 60
•Medically stable
•Agitation present both at screening and baseline
•Agitation not responsive to simple nonpharmacologic interventions and lasting at least 2 weeks prior to enrollment.
•Available Health Care Proxy or other legal representative to give informed consent, and patient assent.
•No planned change in environment for duration of study
•At least one reliable caregiver

Exclusion criteria

•Any intercurrent medical problem that could explain the agitation
•History of major depression or bipolar preceding the onset of dementia
•Other major psychiatric illness preceding the onset of dementia or mental retardation
•Other dementias
•History of alcohol abuse or dependence in the last 2 years
•Delirium (or history of delirium in the last 8 weeks)
•Treatment with other psychotropic drugs except those permitted in the protocol. Patients already treated for agitation with psychotropic medication must be able to successfully discontinue it and tolerate a washout period of no less than 1 week.
•Treatment with non-psychotropic, centrally active drugs believed to contribute to patient's agitation.
•Severe psychiatric symptoms requiring psychiatric hospitalization or suicidal, homicidal potential.
•History of intolerance to citalopram
•Noncompliance with oral medication or inability to take oral medication
•Modified Hachinski score of 4 or greater

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
3
Other (unclassified)
2

Behavior / neuropsychiatric

3 endpoints
Primary/protocol endpoint

Agitation factor on the Neurobehavioral Rating Scale (NBRS)

descriptive

Secondary/protocol endpoint

Cohen-Mansfield Agitation Inventory

descriptive

Secondary/protocol endpoint

Neuropsychiatric Inventory

Neuropsychiatric Inventory (NPI)

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Total NBRS scores

descriptive

Secondary/protocol endpoint/low confidence

Global Clinical Impression of Change

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.